NCT05127135

Brief Summary

This is a single dose escalation study to evaluate the safety and clinical activity of ThisCART7(Allogeneic CAR-T targeting CD7) in patients with refractory or relapsed CD7 positive T cell malignancies.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2020

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2023

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

3 years

First QC Date

November 9, 2021

Last Update Submit

November 9, 2021

Conditions

T-Acute Lymphoblastic LeukemiaT-cell Non-Hodgkin LymphomaT-cell Acute Lymphoblastic Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-related grade≥3Adverse Events or SAE

    Therapy-related adverse events or SAE will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

    within 4 weeks after infusion

Secondary Outcomes (1)

  • Objective Response Rate

    4 to 6 weeks after infusion

Other Outcomes (3)

  • Progression free survival time

    3 years

  • Overall survival time

    3 years

  • Event-free survival

    3 years

Study Arms (1)

ThisCART7 cells injections

EXPERIMENTAL

In this study, allogeneic anti-CD7 CAR T Cells(ThisCART7 cells) is used to treat patients with refractory or relapsed CD7 positive T cell malignancies.

Biological: ThisCART7 cells

Interventions

ThisCART7 cellsBIOLOGICAL

0.5-6 x 10\^6 CAR T cells per kg body weight

ThisCART7 cells injections

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with relapsed and refractory CD7 + T cell hematologic malignancies (including, but not limited to, T-cell leukemia, extranodal NK/ T-cell lymphoma nasal, peripheral T-cell lymphoma, enteropathy associated T-cell lymphoma and anaplastic T-cell lymphoma, etc.);
  • No alternative treatment options deemed by investigator;
  • Measurable or detectble disease at time of enrollment;
  • Age 18-70 years old, no gender and race limited;
  • Eastern cooperative oncology group (ECOG) performance status of ≤2;
  • Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO);
  • Estimated life expectancy \> 12 weeks deemed by investigator;
  • Serum creatinine ≤ 1.5 upper limit of normal (ULN);
  • Serum ALT/ AST ≤ 5 upper limit of normal (ULN);
  • Signed informed consent form (ICF).

You may not qualify if:

  • Women in pregnancy or lactation;
  • Uncontrolled infection;
  • Active hepatitis B virus or hepatitis C virus infection;
  • Concurrent use of corticosteroids or other immunosuppressant medications for chronic disease;
  • Prior treatment with an allogeneic stem cell transplant within 100 days;
  • Grade 2-4 Active graft versus host disease;
  • History of HIV infection;
  • With central nervous system involvement;
  • Patients combine with other disease cause neutrophil count (ANC) \< 750/uL or PLT\< 50,000/uL.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, Anhui, China

RECRUITING

Fundamenta Therapeutice Co.,Ltd

Suzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLymphoma

Study Officials

  • Wang Xingbing

    The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Jun, Ph.D

CONTACT

+86-18662604088jli@ctigen.com

He Ling

CONTACT

+86-18626100886lhe@ctigen.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2021

First Posted

November 19, 2021

Study Start

January 22, 2020

Primary Completion

January 24, 2023

Study Completion

December 24, 2023

Last Updated

November 19, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)